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Biomedical subjects

S Luzi

Publications and source records attributed to S Luzi.

At least 37 records · Page 2Linked to original sources

Predictors of adverse events after the administration of acellular and whole-cell diphtheria-tetanus-pertussis vaccines.

Recurrence of adverse events, the effect of site of injection, and concurrent administration of oral polio vaccine (OPV) and hepatitis B vaccine (HBV) on reactogenicity were assessed in recipients of two acellular pertussis vaccines given in combination with diphtheria and tetanus toxoids (DTaP), one whole-cell DTP vaccine (DTPwc) and one DT vaccine during a double blind, randomized, controlled clinical trial. Local and systemic side reactions were more likely to recur after the administration of DTaP and DT compared with DTPwc. In all vaccine groups, injection in the buttock was associated with a lower rate of common adverse events compared with injection in the thigh, while simultaneous administration of OPV and/or HBV did not increase the risk of onset of side reactions.

Diphtheria↗

Prognostic significance of anemia and role of erythropoietin in radiation therapy.

Anemia represents a common finding in cancer patients, especially at an advanced stage. Anemia has an impact on the quality of life and at the same time seems to markedly limit the disease control that can be achieved with radiotherapy. The results of a series of clinical studies published in the last decade allow some general observations: 1. the administration of erythropoietin, especially if associated to ferrous sulfate is able to increase hemoglobulin levels in cancer patients undergoing radiation therapy (combined with concomitant chemotherapy); 2. erythropoietin stimulation of hemoglobin in anemia decreases the need for blood transfusion in cancer patients; 3. tumor response to radiation therapy appears to be enhanced by erythropoietin-induced hemoglobulin increase. Further clinical studies are required for assessment of indications, identification of optimal administration modalities, cost-analysis of this promising therapy for patients undergoing radiation therapy.

Anemia↗

[Preoperative radiochemotherapy in pancreatic cancer: preliminary results].

AIMS AND BACKGROUND: The prognosis of pancreatic cancer remains poor. Surgery, when feasible, is rarely curative. Radiation therapy (RT) and concomitant 5-fluorouracil (5-FU) have been shown to improve survival in locally advanced pancreatic cancer. In an attempt to improve resectability and disease control, we used preoperative chemoradiation in a combined modality therapy protocol. The purpose of this study was to evaluate our initial results in terms of acute toxicity and response. METHODS: From October 1995 to May 1998, 20 patients (11 males, 9 females; mean age, 60.1 years; median follow-up, 28 months) with unresectable (12 patients) or resectable (8 patients) non-metastatic pancreatic tumors, received external beam radiation (39.6 Gy) plus 5-FU (96 hours continuous infusion, days 1-4 at 1000 mg/m2/day). After 4 weeks, patients were evaluated for surgical resection. In resected patients, electron-beam intraoperative radiation therapy (10 Gy) was given before reconstruction. Thereafter, in resected patients, adjuvant chemotherapy was prescribed (6 courses: 5-FU, mitomycin C, adriamicine). RESULTS: During chemoradiation, no patients developed grade 3-4 acute toxicity. Three out of twelve (25%) patients with unresectable tumors had tumor downstaging. No patients showed partial or complete responses. Four out of twenty patients (20%) had minimal tumor response. Three patients showed disease progression after chemoradiation (liver or peritoneal metastases). Nine patients underwent surgical resection and IORT, with 1 postoperative death. The median survival time for the 20 patients was 9.4 (18.5 and 8.3 months in resected and unresected patients, respectively). CONCLUSION: Our preliminary results suggest that preoperative 5-FU chemoradiation was well tolerated and may result in tumor downstaging but the response-rate is still low. Based on the impact of surgical resection on survival, an improvement in local response rate is necessary.

Actuarial Analysis↗

Economic and organizational aspects in the management of prostate cancer.

In the last decade a rapid increase in the incidence of prostate cancer was observed. The reasons for this increase are associated to the progressive population aging, especially in the developed countries as well as to the growing number of identified cases with the widespread use of prostate specific antigen. A number of aspects of the disease are still to be considered in depth: the natural history of the disease in patients with early diagnosis, the potential costs of screening programs in financial, social and psychologic terms, the effectiveness and especially cost-effectiveness of different treatments and follow-up for local and advanced forms. Because of the long natural history of prostate cancer and the effectiveness of hormonal treatments used as salvage after failure of primary therapy, the differences in survival among the various therapeutic options, from radical prostatectomy to radiotherapy, or simple clinical control in selected cases are probably minor. This is the reason why future clinical studies should necessarily be based on multidimensional evaluations, taking into account the clinical outcome as well as the quality of life and costs of the different treatment modalities examined.

Combined Modality Therapy↗

Research trends in the treatment of prostatic neoplasms.

Prostatic carcinoma, in the male population ranks first as incidence and second as cause of oncologic mortality. In the last decades, significantly better clinical results were achieved both in diagnosis and therapy. The latter covers a broad range of possibilities, including standard surgery, nerve-sparing surgery, combined surgery and hormonotherapy, cryosurgery, external beam radiotherapy, brachytherapy, conformal radiotherapy, combined hormone and radiation therapy, as well as conventional hormonotherapy. However, there is still much controversy on the role of the screening, the most appropriate staging modalities, the most adequate treatment in the various presentations of the disease. The present trends of the clinical research in this field are directed towards the identification of factors involved in the onset of this neoplasm and the possibility of decreasing its incidence with programs of chemoprevention, the identification of new biological markers able to assess the biological potential of the disease, the comparison between the main treatment modalities of localized carcinoma (surgery, brachytherapy, external beam radiotherapy) and the definition of parameters predictive of the response to the various treatments to better personalize the therapy of the single patient, the development of treatments based on genetic therapy and of effective systemic therapies able to control the hormone-resistant advanced disease and to clarify the impact of the different therapies on the quality of life and health care costs.

Humans↗

Research trends in the treatment of neoplasms of the exocrine pancreas.

To-date, the therapeutic standards, defined by randomized studies for carcinoma of the exocrine pancreas are disappointing. Obviously, there is much interest in the improvement of these results based on the evidence of additional clinical trials. To identify some trends in the clinical research in this field, some characteristics of 31 ongoing trials, described in the web site of the National Cancer Institute were examined. 28/31 trials are coordinated by Centers of the U.S.A. and 3/31 trials specifically concern symptom palliation. Excluding the latter, 4 trials enroll patients with operable neoplasms, 8 with inoperable tumors, 4 with metastatic neoplasm and 12 involve both latter categories. Four of the 5 phase I or I-II studies concern concomitant radiochemotherapy of inoperable neoplasms; the 16 phase II studies and the 7 phase III studies involve the use of different combined modality therapies in all patient categories. Overall, 18 trials test innovative treatment modalities (new drugs, immunotherapy, monoclonal antibodies). Eight trials include the evaluation of the quality of life between endpoints. Based on this assessment of some of the ongoing clinical trials, hopefully, there will be: 1. a greater interest in the prospective therapies for this neoplasm, especially at the European level, considering the high incidence of this disease; 2. more careful attention to the possibility of downstaging of locally advanced neoplasms considering the present, proven possibility to achieve better clinical responses in pancreatic carcinoma; 3. a more widespread interest in the establishment of parameters for the quality of life, considering the frequently "palliative" intent of available therapies.

Clinical Trials as Topic↗

Quality handbook in radiotherapy. Brachytherapy: personal experience.

Brachytherapy is a conventional method of radiation therapy characterized by peculiar technical, clinical, operational and radioprotection problems. Therefore, the management of a service or department of brachytherapy requires a specific organization aimed at Quality Assurance. In this report, the personal experience with the drawing up of a Quality Handbook of brachytherapy with reference to the method used and the structure of the document, is described.

Brachytherapy↗

[131I]metaiodobenzylguanidine treatment of malignant pheochromocytoma: experience of the Rome group.

Five cases of malignant pheochromocytoma (3 men and 2 women, aged 26-43 years) were treated with [131I]metaiodobenzylguanidine (131I-MIBG). One patient had a voluminous adrenal tumor and multiple distant metastases; two patients had a recurrent tumor; two others a post-surgical residual tumor. The therapeutic procedure essentially consisted of single doses (2.6-7.4 GBq) of 131I-MIBG administered by slow i.v. infusion, given in several therapeutic courses at 1-5 month intervals. The treatment resulted in a complete response in one case with residual tumor and in a partial response in the case with disseminated disease. Two cases showed stabilization of the disease, whereas therapy was ineffective in the fifth case. Nevertheless, pain relief was observed in this patient. The treatment had a very low toxicity and was well tolerated by all patients.

3-Iodobenzylguanidine↗

The role of [131I]metaiodobenzylguanidine in the treatment of medullary thyroid carcinoma: results in five cases.

Therapeutic doses of [131I]metaiodobenzylguanidine (131I-MIBG) were administered to 5 patients, 3 men and 2 women aged from 33 to 66 years, with proven medullary thyroid carcinoma (one "intermediate" papillary/medullary tumor). The treatment procedure consisted of single doses (3.7-8.5 GBq) of 131I-MIBG given by slow i.v. infusion at 2-8 month intervals. In two advanced-stage patients the treatment played an important palliative role, ranging from an objective response (substantial, but not complete, regression of the tumor) to pain relief which was significant for these patients. In three other cases with residual/recurrent tumor, 131I-MIBG complemented conventional treatment in the attempt to effect a cure which actually was achieved in one case. The only side-effect observed was a transient, mild hematologic toxicity in some cases.

3-Iodobenzylguanidine↗

Concomitant radiochemotherapy in rectal cancer: methodology and indications.

Concomitant radiochemotherapy (CRC) is based on the administration of chemotherapeutic agents concurrently with radiation therapy. It is aimed at the spatial cooperation of radiotherapy (ERT) and chemotherapy and the enhancement of the local action of radiotherapy. In this study the role of ERT enhancement in the treatment of rectal cancer, is analyzed. 5FU is the commonly used drug. Clinical and experimental evidence indicates radiotherapy to be enhanced when the drug is administered in continuous infusion after radiation and for a suitable dose of 5FU. In these conditions, toxicity is usually mild. In contrast, when the drug is administered as bolus, the experimental evidence seems to indicate only additivity. However the clinical experience has shown an improvement in local control and survival at the expense of a higher toxicity. In patients with resectable lesions at high risk for local recurrence, randomized CRC studies have shown a high rate of local control between 85% and 90%, a 5-year survival between 55% and 60%, significantly better as compared to control arms: exclusive surgery (GITSG7 175), exclusive ERT (NCCTG), bolus CRC (Intergroup). Acute toxicity is mostly hematological and gastrointestinal. In patients with lesions unresectable for cure, CRC allows high surgical radicality (85-90%). Complete pathologic response is 4 to 20%. Local control is high (80-90%) and 3-year survival is 70 to 90%. Grade 3-4 acute gastrointestinal toxicity was shown to be higher in combinations with bolus 5FU. In recurrence CRC has been used for palliation. Control of pain to the pelvis was similar to that achieved with radiotherapy alone. In a single experience was CRC used preoperatively and results seem encouraging.

Combined Modality Therapy↗

Carcinoma of the pancreatic head area. Therapy: intraluminal brachytherapy.

Intraluminal brachytherapy (Il-BRT) consists in the treatment of neoplasms by the positioning of radioactive sources in the lumen of cavitary organs such as the esophagus, the trachea, the bronchi and bile ducts. This procedure has been used to deliver relatively high doses of irradiation to bile duct and periampullary carcinomas while sparing the adjacent organs. Results of a number of reports appeared in the last fifteen years document the feasibility and tolerance of the procedure. Moreover these data seem to suggest that Il-BRT is able to prolong the survival of patients undergoing biliary drainage and that its use as boost dose in external beam radiotherapy (ERT) enhances the results of the latter. Combined ERT+Il-BRT is associated to an incidence of gastrointestinal ulcerations related to the total dose delivered. Better patient selection and standardization of reference dose represent prerequisites for testing this procedure in prospective randomized trials.

Brachytherapy↗